Pt info unknown/ not provided.Lot#/model# : unknown/not provided.Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product lot number was not provided.A partial number has been provided.Device manufacture date: unknown, as the lot number of the device was not provided.Reporter's email address: unknown/not provided.Reporter first name is unknown as it was not provided.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.The patient interface (pi) suction ring may lose suction during a procedure.Label copy states corneal fixation vacuum loss can occur.There are several factors that may contribute to suction issues such as doctors technique in applying the suction ring to the cornea, doctors technique in squeezing the pi clip to secure the suction ring to the pi cone and patient anatomy affecting the interface between the patients cornea and the suction ring.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
|